A Clinical Study on New Hair Biofactors®

Summary

One-hundred and forty-eight participants with varying degrees of male pattern baldness (androgenic alopecia) participated in an open-ended study using an all natural compound solution to determine the effects of hair regrowth.

The participants were photographed and initial hair counts were done in a 2.5 cm diameter area of their balding scalp. After five months of treatment, the participants were re-photographed and hair counts were done on the same 2.5 cm diameter area of the scalp. The results indicate that 85.7% of the men in the study had an increase in their terminal hairs of 30% or greater. When evaluating the percent increase more closely, we find that we can break the data down into three separate groups:

1. Significant regrowth
2. Moderate regrowth
3. No change

Showing significant regrowth was 40.8% of the study group and had an increase of 100% or greater (doubling, tripling, or more) of terminal hairs counted on their five month post-treatment photo as compared to their initial pre-treatment photo. Of this group, the highest increase of hairs was 472%, and the lowest increase was 102% with the mean at 193.7% increase of hairs.

The group of men showing moderate regrowth, which we classed as 30%-100% increase in terminal hair regrowth, was 44.9% of the study group. The mean increase of that group was a 61.5% increase of hair regrowth.

The remainder of the group, classed as no change, was 14.3% of the study group, with an average of 6.7% increase in regrowth.

Participants were told to use at least one bottle per month (five bottles in five months) but were allowed to use more if desired. We did not see any significant advantage to using more than one bottle per month. Our conclusion is that the stimulatory effect of the compound is achieved at the use rate of one bottle per month.

The age range of the participants in the ability to regrow hair was not a factor. The range of the participants in this study was 24-68 years old, with the average age being 38.7 years.

In summary, this study concludes that the natural herbal extract solution has a stimulatory effect on hair growth for at least 8 out of 10 men with androgenic alopecia (balding). The earlier stages of balding appear to respond to a higher degree, but significant improvement was seen in participants at all stages of baldness. There appears to be an optimum rate of use of the product, and age does not seem to be a factor in response.

Introduction

Hair performs no vital function relative to the medical well being of humans. Yet the psycho-social implications can never be underestimated. Scalp hair can be the crowning glory for the femininity of women and a potent symbol of masculinity and security in men.

Reversal of male pattern baldness in men has for centuries eluded science and medicine. Minoxidil (commonly known as Rogaine) and Diazoxide have shown in past studies to reverse balding in men, although in only small percentages of the patients studied.

This study demonstrated the safety and efficacy of a natural compound solution to stimulate hair growth. The solution is coupled with a treatment regimen which includes scalp cleansing and proper scalp massaging.

Patients and Methods

One hundred and sixty four males with male pattern baldness from the greater Toronto area were studied at the hair clinic. After informed consent and observing past medical histories and years of balding, the men were selected. Patients that were using any form of cortico-steroids, cytotoxic agents, or any other form of hair regrowth agent, like Minoxidil, were excluded from the study.

It was decided to run an open-ended study. All men were instructed and shown very carefully how to use the specially formulated scalp cleanser and all natural compound solution. Once this was handled, all the men were photographed with a high resolution Minolta "instant pro" camera. The room was brightly illuminated for close examination of the scalp and individual hairs. The camera was positioned exactly 25 cm from the balding or thinning areas with frontal, top, and rear pictures taken as needed. The participants were asked to wait for the picture to develop and sign their respective photos.

Administration and Dosage

The all natural compound solution was supplied at no charge to the participants. Each person received 250 ml of the alcohol based all natural compound solution along with 250 ml of a specially formulated deep scalp cleanser. They were all individually and carefully instructed on the proper usage of both the scalp cleanser and the all natural compound solution.

Evaluation and Assessment Grading

The photos taken prior to the treatment were closely evaluated. Before the treatment was initiated, a 2.5 cm circle in diameter was drawn in the balding area, always very near the border of the area demonstrating the most significant hair loss. Initial hair counts were done using a 4X magnifying lens mounted on a circular fluorescent lamp. Independent counts were made by two of us (MS and AJF), times 2, and the average of the two counters was used for statistical purposes. The hairs in the 2.5 cm area were counted, including hairs on the circular boundary. The final counts on the participants were done after five (5) months on the treatment program. The same criteria from the initial photograph was used to determine the exact location of the 2.5 cm area on the scalp and the same procedure was used to count hair roots within and on the boundary of the inscribed circular area.

At the conclusion of the five (5) month treatment program, the photos were graded under the following categories: A zero (0) grading was given to the photos that revealed no change from their initial pre-treatment photo. A grading of one (1) was given to the participants with moderate regrowth of hair from their respective original photos. And a grading of two (2) was assigned to the men with a significant regrowth of hair from their original photos.

Results

Of the one-hundred and sixty-four participants starting the study, eleven were eliminated because of their repeated absence from photo sessions and failure to use the product. Four were eliminated due to their irregular use of both the scalp cleanser and the all natural compound solution, and one person was discontinued because he relocated to another country. The remainder of the 148 participants applied the all natural compound solution at least twice daily for the five months as required for this study.

The regrowth of hair was first noticed on some participants as early as two months into the treatment. By the third month, a substantial number of men demonstrated moderate regrowth; both fine vellus hairs (peach fuzz) and darker pigmented intermediate and terminal hairs were observed. It is noteworthy to mention that the fine vellus hairs, although visible to the naked eye, were not detectable by the photos. Thus all of our quantitative and qualitative assessments were made from any intermediate and/or terminal hairs.

Criteria for Analysis of Response to All Natural Compound Solution

The following parameters were used to classify the magnitude of hair regrowth: Subjects with less than a 30% increase in intermediate and/or terminal hairs were counted as no change. The moderate improvement group we determined were the men that showed an increase of final hair counts of greater than 30% and up to a 100% increases of terminal hairs, in their five month photos as compared to their original photos. The last group we identified was the significant increase group. This group showed the best improvement of all the men in the study, and we included those with hair count increases of 100% or greater.

Response of the All Natural Compound Solution on Baldness

Although the qualitative and quantitative assessments were done independently, there was a strong correlation between the two groups. Overall, 88% of the qualitative group showed some degree of improvement. Of the group studied quantitatively, 85.7% showed a degree of regrowth (within 95% confidence limits). With the qualitative group, 6 of 50 men were categorized as having no change (category 0), representing 12% of the total. In the quantitative group (98 participants), 14 men, or 14.3% did not show any increase in hair counts. The average hair count increase for this group was 6.7%. So most subjects in this group did regrow some hair, but not a noticeable amount.

The moderately improved qualitative group (category 1) consisted of 16 participants, or 32%. In the quantitatively studied group, 44 of 98 men fell into the range of +30% to +100%. This represents 44.9% of the men. The range of increase was 32% to 98%, with the mean at 61.5% The participants showing significant regrowth in the qualitative group (category 2) were 28 of 50, or 56%. In the quantitatively studied group, the number of men with significant regrowth (greater than 100%) was 40 of 98, or 40.8%. These men had hair count increases of 100% or more. The range of hair count increases was 102% to 472%, with a mean increase of 194%. The photograph of these men and women showed significant cosmetic changes which correlates very well with our quantitative findings.

Pattern of Hair Regrowth

From the photos taken monthly during the course of the study, a pattern of regrowth was observed in those participants who demonstrated a significant increase in hair counts over the five months. The first countable hairs were seen after 10-12 weeks of treatment and were first detected on the crown or vertex of the head. Following further treatment, hair was then observed regrowing in the margin of fringe of the thinning or balding areas of the scalp. Hair regrowth in the fronto-temporal region of the scalp was noted after 16-20 weeks of treatment, and this region appeared to be the most resistant to regrowth to date.

Correlation of Response with Age

The average age of the 176 participants was 38.7 years. The mean ages for their respective groups were as follows: The no change group was 41.8 years. The moderate group was 36.7 years. And the significant group was 38.5 years. The youngest participant in the study was 24 years old, and the oldest participant was 68. There was no correlation between age and response to the treatment.

Discussion

This open-ended study has demonstrated the hair regrowth response of 148 men who have been treated with an all natural compound solution applied topically to balding or thinning regions of the scalp. The treatment program included regular scalp cleansing with a natural extract scalp cleanser and application of at least 5-10 ml of the all natural compound solution at least twice daily. The data showed that hair counts increased significantly for approximately 85% of the participants in the five month period.

The study methodology implies that the results obtained relate not only to the all natural compound solution used in the treatment, but also the overall treatment regimen. From previous Minoxidil (Rogaine) papers, it was determined by them that a reasonable expectation for a "placebo-type" effect was a 10-15% increase in hair counts. Thus, by setting the cut-off in this study for moderate regrowth at a 30% increase, any increase due to a "placebo-type" effect is discounted.

An attempt was made to correlate the response (either no change, moderate change, or significant change) with a number of factors. None of the factors studied gave a strong correlation, although there were some trends noted. The number of years of balding or thinning hair did not appear to have any correlation with the final results. However, it should be noted that the number of years thinning was a number given by the participants, and could not be verified accurately. Thus it is a subject of assessment and may not be very reliable. To help balance this uncertainty, the results were grouped. Regardless of the groupings used, there was no grouping which demonstrated a significant correlation with results.

In terms of hair regrowth, this all natural compound solution appears to be more effective than Minoxidil (Rogaine) and has no known side effects. A study by Alanis showed that a 2% Minoxidil preparation applied topically increased hair counts by about 24% after 20 weeks. This study showed an increase of 89% in the same time period. Because of the differences in locating the measured regions of the scalp, these results are not directly comparable, but in a population study, Alanis's results showed that 34-46 out of 83 participants (48%) had no growth after 24 weeks, whereas our results show only 14 out of 98 (14%) had no growth after 20 weeks. Thus, our conclusion is that this product does stimulate regrowth of hair in cases of androgenic alopecia (balding), and that over 85% of men will respond favorably to the treatment.

Figure 3

Figure 4

Figure 3 - Photo-micrograph of a scalp biopsy demonstrating the immuno-histochemical localization of DHT (died red) in the epidermal layer of the scalp.

Figure 4- Photo-micrograph of the same scalp after treatment.

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